Penile prosthesis implantation device

ABSTRACT

A penile prosthesis implantation device includes a barrel having a bore, and an obturator that is received within the bore and is configured to slide along a longitudinal axis of the bore relative to the barrel. A distal end of the obturator includes a needle clamp and one or more bore engaging members. The needle clamp is configured to hold a thread attachment end of a needle. Each bore engaging member includes a surface that engages an interior wall of the bore. A gap extends between a central portion of the obturator and the one or more bore engaging members.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 14/337,926, filed Jul. 22, 2014, which is a continuation ofU.S. patent application Ser. No. 14/037,797, filed Sep. 26, 2013, nowU.S. Pat. No. 8,864,651, which is a continuation of U.S. patentapplication Ser. No. 12/644,805, filed Dec. 22, 2009, now U.S. Pat. No.8,545,391, which is based on and claims the benefit of U.S. provisionalpatent application Ser. No. 61/140,173, filed Dec. 23, 2008 and U.S.provisional patent application Ser. No. 61/140,350, filed Dec. 23, 2008.The above-referenced applications are hereby incorporated by referencein their entirety.

BACKGROUND

The present disclosure relates to medical devices used in implantsurgery. More specifically, the present disclosure relates to a penileprosthesis implantation device used to assist in the implantation ofpenile prostheses cylinders in the corpus cavernosae of a patient. Insome instances, these cylinders are inflatable, which are connected to afluid-filled reservoir with a pump and valve assembly. Another type ofcylinder is non-inflatable and does not require the pump and valveassembly.

The penile implantation operation is an invasive treatment. To reach thecorpus cavernosae and implant the cylinders, the surgeon will first makean incision at the base of the penis, such as where it meets thescrotum. The patient is prepared for the cylinders by dilating eachcorpus cavernosum.

Once the patient has been prepared, the surgeon will insert a medicaldevice known as a Furlow insertion tool with a Keith needle into thedilated corpus cavernosum. The Furlow tool is a well known and oftenused device in the art and is described in U.S. Pat. No. 4,244,370,which was filed in 1978. The Furlow tool is a long slender device havinga hollow barrel with a plunger device known as an obturator at therearward end. The Keith needle is also a well-known article used in manyareas of medicine. The Keith needle looks like a heavy sewing needle andis used to pierce tissue. The Keith needle fits within the barrel of theFurlow tool and is ejected from the forward end with the obturator.

In order to install the penile prosthesis cylinder in one of the corpuscavernosum, the Keith needle is attached to a suture that is alsoattached to the cylinder. The Keith needle with a threaded suture isthen inserted into the distal opening of the Furlow tool. The Furlowtool is advanced into the corpus cavernosum until the forward end isinside of the crown of the penis, or glans. At this point, the cylinderand part of the suture attached to the cylinder remain outside of thepatient's body. The Furlow tool is used to force the Keith needle out ofthe barrel and through the glans. The surgeon grasps the Keith needlefrom outside of the body and pulls it from the penis leaving the suturethreaded through the corpus cavernosum. The Furlow tool is withdrawnfrom the penis. The suture is then pulled to draw the cylinder into theincision and the corpus cavernosum. Once the implant is in place, thesuture is removed. This procedure is then performed again on the othercorpus cavernosum.

Problems with the above-described system include the numerousopportunities for medical personnel, the patient, or an inflatablepenile prosthesis to become pierced by the Keith needle. For example,medical personnel must handle the Keith needle while threading thesuture through the eye of the Keith needle and during insertion of theneedle into the Furlow tool. Additionally, while the Keith needleprovides a slight interference fit within the barrel of the Furlow tool,it may also fall out during handling, thereby presenting additionalopportunities for medical personnel, the patient or the penileprosthesis to become pierced by the Keith needle. Also, threading thesuture through the eye of the Keith needle lengthens surgical time,increasing the chance of infection, and can be a source of frustrationfor the surgeon when threading the suture is difficult.

The discussion above is merely provided for general backgroundinformation and is not intended to be used as an aid in determining thescope of the claimed subject matter.

SUMMARY

Embodiments of the invention are generally directed to a penileprosthesis implantation device. One embodiment of the penile prosthesisimplantation device comprises a barrel having a bore, an obturator and aneedle clamp. The obturator has a longitudinal axis, a first end and asecond end. The second end of the obturator is adapted for slidableinsertion into the bore of the barrel. The needle clamp is coupled tothe second end of the obturator and comprises first and second pinchingsurfaces that are separated by a gap.

Another embodiment of the invention is directed to a needle guard thatattaches to the penile prosthesis implantation device that includes abarrel having a bore, an obturator having a first end and a second end,the second end adapted for slidable insertion into the bore and a needlewithin the bore adjacent the second end of the obturator. The needleguard generally operates to secure a needle within the barrel of thedevice. One embodiment of the needle guard comprises first, second andthird members. The first member is configured to cover an end of thebarrel at which the bore is exposed. The second member is configured toengage the first end of the obturator. The third member is coupled tothe first and second members of the needle guard.

Yet another embodiment of the invention is directed to a kit comprisinga penile prosthesis implantation device, a penile prosthesis, a sutureand packaging. The device includes a barrel having a bore, an obturator,a needle clamp and a needle. The obturator has a longitudinal axis, afirst end and a second end, which is adapted to slide within the bore.The needle clamp is located at the second end of the obturator andcomprises first and second pinching surfaces separated by a gap. Theneedle has a connecting end that is held between the first and secondpinching surfaces, and a pointed tip opposite the connecting end. Theneedle is recessed within the bore adjacent an end of the barrel. Thesuture has a first end connected to the connecting end of the needle,and a second end connected to the penile prosthesis. The packagingcontains the device, the penile prosthesis, and the suture.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a penile prosthesis implantationdevice in accordance with embodiments of the invention.

FIG. 2 is a magnified cross-sectional view of a needle clamp of thedevice of FIG. 1.

FIG. 3 is a side cross-sectional view of a needle clamp in a clampingposition in accordance with embodiments of the invention.

FIGS. 4 and 5 respectively are isometric and cross-sectional views of apenile prosthesis implantation device, formed in accordance withembodiments of the invention, in a retracted position.

FIGS. 6 and 7 respectively are isometric and cross-sectional views of apenile prosthesis implantation device, formed in accordance withembodiments of the invention, in an extended position.

FIG. 8 is a cross-sectional view of a penile prosthesis implantationdevice in accordance with embodiments of the invention.

FIG. 9 is a magnified view of a needle clamp of the device of FIG. 8.

FIG. 10 is a cross-sectional view of a needle guard in accordance withembodiments of the invention.

FIG. 11 is a top plan view of a needle guard in accordance withembodiments of the invention.

FIG. 12 is a cross-sectional view of a needle guard in accordance withembodiments of the invention.

FIG. 13 is a schematic diagram of a kit in accordance with embodimentsof the invention.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

FIG. 1 is a cross-sectional view of a penile prosthesis implantationdevice 100A in accordance with embodiments of the invention. The device100A is configured for the use in the insertion of a penile prosthesis101, a tip end 102 of which is shown in FIG. 1, into the corpuscavernosa of the penis of a patient for the treatment of impotence, in asimilar manner as that described above. One embodiment of the device100A comprises a barrel 104, an obturator 106 and a needle clamp 108A.The barrel 104 has a bore 110 that is generally axially aligned with alongitudinal axis 112 of the obturator 106. In accordance with oneembodiment, most of the components of the device 100A are formed ofplastic.

The needle clamp 108A is configured to grasp a thread attachment orconnecting end 114 of a needle 116, such as a Keith needle. Embodimentsof the needle 116 include various shapes, such as straight, crooked likea lightning bolt as shown in FIG. 1, or other desired shape. In oneembodiment, the barrel 104 is designed such that the needle 116 fitsinside the bore 110 with a light interference with the interior surface117 of the bore. In one embodiment, friction between the needle 116 andthe surface 117 preferably holds the needle 116 within the bore 110during normal handling of the device 100A.

The needle 116 includes a piercing end 118 used to pierce the glans ofthe penis. In one embodiment, a suture 120 is coupled to the threadattachment end 114 of the needle 116 and the tip end 102 of the penileprosthesis 101. In one embodiment, this coupling of the suture 120 tothe thread attachment end 114 and the tip end 102 of the penileprosthesis is performed in accordance with the method described in U.S.Pat. No. 7,407,482, which is incorporated herein by reference in itsentirety.

The needle clamp 108A is either attached to, or formed integral with, adistal end 122 of the obturator 106. One embodiment of the clamp 108Acomprises pinching members 123A and 123B respectively having opposingpinching surfaces 124A and 124B, which are best shown in the magnifiedcross-sectional view of the needle clamp 108A provided in FIG. 2. Thepinching surfaces 124A and 124B are separated by gap 126.

In general, the needle clamp 108A includes a receiving position 128, inwhich the needle clamp 108A is poised to receive the thread attachmentend 114 of the needle 116, as shown in FIGS. 1 and 2. In one embodiment,the needle clamp 108A is positioned in the receiving position 128 inresponse to the extension of the needle clamp 108A outside of the barrel104, as shown in FIG. 1. In one embodiment, the pinching members 123Aand 123B are biased such that they separate from each other in theradial direction relative to the longitudinal axis 112 when the clamp108A is moved to the receiving position 128.

The clamp 108A also includes a clamping position 130, which isillustrated in the side cross-sectional view of FIG. 3. Note that thesutures 120 and the penile prosthesis 101 (FIG. 1), which may beattached to the needle 116, are not shown in FIG. 3 in order to simplifythe illustration. When the needle clamp 108A is moved from the receivingposition 128 to the clamping position 130, the pinching members 123A and123B are biased toward each other in the radial direction relative tothe longitudinal axis 112 such that the corresponding pinching surfaces124A and 124B pinch the thread attachment end 114 of the needle 116 andsecure the needle 116 to the obturator 106.

In one embodiment, the needle clamp 208A comprises at least onedeflector portion, such as deflector portion 132A or 132B, that isaxially displaced from the longitudinal axis 112 of the obturator 106.When the needle clamp 108A is in the receiving position 128, thedeflector portions 132A and 132B are positioned outside of the barrel104, as shown in FIGS. 1 and 2. The needle clamp 108A is moved to theclamping position 130 by sliding the obturator 106 relative to thebarrel 104 in the axial direction to pull the deflector portions 132Aand 132B within the bore 110 of the barrel 104, which in turn drives thepinching members 123A and 123B toward each other in the radial directionto move the needle clamp 108A into the clamping position 130, as shownin FIG. 3.

Thus, the engagement of the deflector portions 132A and 132B with theinterior surface 117 of the barrel 104 biases the first and secondpinching surfaces 124A and 124B toward each other as the clamping membermoves from the receiving position 128 to the clamping position 130. Thismovement of the pinching members 123A and 123B also causes a reductionin a length of the gap 126 between the pinching surfaces 124A and 124Bas the clamp 108A moves from the receiving position 128 to the clampingposition 130. This reduction in the length of the gap 126 causes thethread attachment end 114 of the needle 116 to be pinched by thesurfaces 124A and 124B thereby securing the needle 116 within the clamp108A.

While the needle 116 is secured within the clamp 108A, the needle 116along with the suture 120 can be held within the bore 110 of the barrel104 until it is necessary to deploy the needle, such as after thepiercing end 118 is passed through the glans of the penis. The needle116 can be released by moving the obturator 106 in the axial directionto place the clamp 108A in the receiving position 128. This allows theneedle 116 to be pulled through the glans of the penis, for example.

In one embodiment, the barrel 104 includes a stop portion or member 140that protrudes within the bore 110 and restricts the axial movement ofthe obturator 106, as shown in FIG. 3. In one embodiment, the barrel 104comprises first and second ends 142 and 144. The internal diameter ofthe bore in the first end 142 is greater than the internal diameter ofthe bore 110 in the second end 144. The reduction in the diameter of thebore 110 from the first end 142 to the second end 144 forms the stop140. In one embodiment, the deflector portions 132A and 132B engage thestop member 140 to prevent further axial movement of the obturator 106and clamp 108A along the longitudinal axis 112 in the direction that istoward the second end 144 of the barrel 104.

In operation, the obturator 106 is slid within the barrel 104 through anopening 146 at the first end 142 such that the deflector portions 132Aand 132B extend beyond the bore 110. This places the clamp 108A in therelease position 128, in which the pinching members 123A and 123B aswell as the corresponding pinching surfaces 124A and 124B are separated,as shown in FIGS. 1 and 2. The thread attachment end 114 of the needle116, which is coupled to the tip end 102 of the penile prosthesis by thesuture 120, is received within the gap 126. The obturator 106 is thenslid within the barrel 104 along the longitudinal axis toward the secondend 144 such that the clamp 108A is retracted within the bore 110 at thefirst end 142 of the barrel 104. This causes the deflector portions 132Aand 132B to engage the interior surface 117 of the barrel 104 anddeflect the pinching members 123A and 123B radially causing the gap 126to be reduced and the pinching surfaces 124A and 124B to pinch thethread attachment end 114 of the needle 116. With the needle 116 securedbetween the pinching surfaces 124A and 124B of the clamp 108A, theobturator 106 pulls the needle 116 and the attached suture 120 withinthe first end 142 of the barrel 104, as shown in FIG. 3. When thedeflector portions 132A and 132B engage the stop members 140 of thebarrel 104, the needle is preferably fully received within the bore 110of the barrel 104. This is considered the fully retracted position.

When the needle is delivered through the glans penis during theimplantation of a penile prosthesis, the obturator 106 is slid relativeto the barrel 104 from the retracted position to move the clamp 108Ainto the release position 128, which allows the needle to be releasedand easily pulled through the penis.

FIGS. 4-7 illustrate a penile prosthesis implantation device 100B inaccordance with additional embodiments of the present invention.Elements of the device 100B shown in FIGS. 4-7 that are identified bythe same or similar numbers used to identify elements in FIGS. 1-3correspond to the same or similar elements. FIGS. 4 and 5 respectivelyare isometric and cross-sectional views of the penile prosthesisimplantation device 100B while in a retracted position, in which theneedle 116 is retracted within the bore 110 of the barrel 104. FIGS. 6and 7 respectively are isometric and cross-sectional views of the penileprosthesis implantation device 100 while in an extended position, inwhich the needle 116 is extended beyond the barrel 104.

As with the device 100A, the device 100B is configured for use in theinsertion of a penile prosthesis into the corpus cavernosae of the penisof a patient for the treatment of impotence, as described above. Oneembodiment of the device 100B comprises a barrel 104, an obturator 106and a needle clamp 108B. The barrel 104 has a bore 110 that is generallyaxially aligned with a longitudinal axis 112 of the obturator 106.

In one embodiment of the device 100B, the bore 110 of the barrel 104comprises a tapered section 110A at the opening 146. The tapered section110A of the bore 110 has an internal diameter that increases withdistance traveled along the longitudinal axis 112 toward the opening146. As the device 100 is moved from the retracted position (FIGS. 4 and5) to the extended position (FIGS. 6 and 7) by moving the clamp 108Btoward the opening 146 of the barrel 104, the needle clamp 108B opens tothe receiving position 128, shown in FIG. 7. While in the receivingposition 128, the deflector portions 132A and 132B are positioned withinthe tapered section 110A of the bore 110. The larger internal diameterin the section 110A allows the deflector portions 132A and 132B toexpand slightly within the bore 110 thereby increasing the gap betweenthe pinching members 123A and 123B.

In one embodiment, the gap between the pinching members 123A and 123Ballows for an interference fit between the thread attachment end 114 ofthe needle 116 while the needle clamp 108B is in the receiving position128. The thread attachment end 114 can be secured to the needle clamp108B by the interference fit between the pinching members 123A and 123B.One advantage to this receiving position 128 is that one may attach thethread attachment end 114 of the needle 116 to the needle clamp 108Bwithout having to retract the obturator 106.

As the obturator 106 is moved relative to the barrel 104 toward theretracted position, the deflector portions 132A and 132B are compressedby the narrowing of the internal diameter of the bore 110 as the needleclamp 108B is moved from the tapered section 110A to section 110B of thebore 110, which has a narrower internal diameter. The compression of thedeflector portions 132A and 132B within the section 110B of the bore 110drives the pinching members 123A and 123B toward each other therebynarrowing the gap between the pinching members 123A and 123B andsecuring the thread attachment end 114 of the needle 116 within theneedle clamp 108B. Accordingly, the needle clamp 108B moves to thisclamping position 130 as the device 100 moves from the extended positionto the retracted position. In one embodiment, the needle 116 is fullyreceived within the bore 110 of the barrel 104 when the device 100 isthe fully retracted position shown in FIGS. 4 and 5.

In accordance with another embodiment, the obturator 106 includes a stopmember 180 positioned, for example, intermediate a proximal end 210 andthe needle clamp 108B. Additionally, the bore 110 includes a section110C having an internal diameter that accommodates the stop member 180.The section 110B located at the first end 142 of the barrel 104 and asection 110D located at the second end 144 of the barrel 104 haveinternal diameters that are smaller than the internal diameter of thesection 110C of the bore 110. Additionally, the stop member 180 is sizedto prevent it from entering the sections 110B or 110D of the bore 110.As a result, the stop member 180 limits the distance the obturator 106can be moved relative to the barrel 104 between the fully retractedposition shown in FIG. 5 and the fully extended position shown in FIG.7. In one embodiment, the needle clamp 108B is positioned within thetapered section 110A of the bore 110 when the device 100 is positionedin the fully extended position, as shown in FIG. 7.

One embodiment of the device 100B includes a protective member 182 thatsnaps to the shaft 170 of the obturator 106 while the device 100 is inthe fully retracted position, as shown in FIGS. 4 and 5. The protectivemember 182 operates to prevent the obturator 106 from moving from theretracted position to the extended position and thereby prevents theneedle 116 from being unintentionally extended out of the barrel 104.Other similar devices for use with the penile prosthesis implantationdevices of the present invention are described below.

FIG. 8 is a cross-sectional view of a penile prosthesis implantationdevice 100C in accordance with additional embodiments of the invention.The elements illustrated in FIG. 8 and other figures having the same orsimilar labels as the elements of FIGS. 1-7 generally correspond to thesame or similar elements. FIG. 9 is a magnified view of the needle clamp208C shown in FIG. 8. As with the devices 100A and 100B, the device 100Cis configured for use in the insertion of a penile prosthesis into thecorpus cavernosae of the penis of a patient for the treatment ofimpotence, as described above. Accordingly, the sutures 120 and thepenile prosthesis 101 (FIG. 1) may be attached to the needle 116 held bythe device 100C, but are not shown in order to simplify theillustrations.

One embodiment of the device 100C comprises a barrel 104, an obturator106 and a needle clamp 108C. The barrel 104 has a bore 110 that isgenerally axially aligned with a longitudinal axis 112 of the obturator106. In one embodiment, the barrel 104 comprises separate halves thatare secured together using one or more o-rings 184 (shown in FIG. 8),one or more latches, an adhesive, ultrasonic welding, or other suitabletechnique.

The needle clamp 108C is configured to grasp the connecting end 114 of aneedle 116 formed in accordance with the embodiments described above.The needle clamp 108C is either attached to, or formed integral with, adistal end 122 of the obturator 106. One embodiment of the clamp 108Ccomprises pinching members 186A and 186B respectively having opposingpinching surfaces 188A and 188B, which are best shown in the magnifiedcross-sectional view of the needle clamp 108C provided in FIG. 9. Thepinching surfaces 188A and 188B are separated by a gap, which isconfigured to receive the thread attachment end 114 of the needle 116,as shown. The gap between the pinching surfaces 188A and 188B ispreferably selected to be slightly smaller than the thickness of the end114 of the needle 116 to provide an interference fit between thepinching surfaces 188A and 188B and the end 114 of the needle 116.Frictional resistance between the pinching surfaces 188A and 188B andthe end 114 of the needle 116 caused by the interference fit operates tosecure the end 114 of the needle 116 in the needle clamp 108C duringnormal use of the device 100C including handling the device 100C andpiercing the glans of the penis with the end 118 of the needle 116during a penile prosthesis implantation operation. In one embodiment,the end 114 of the needle 116 can be inserted within the gap between thepinching surfaces 188A and 188B by hand.

In one embodiment, the barrel 104 includes a stop member 140 at thesecond end 144 of the bore 110, such as a shoulder portion, that engagesa portion of the distal end 122 of the obturator 106 to prevent thedistal end 122 of the obturator 106 from being pulled out of the end 144of the barrel 104. In accordance with another embodiment, the barrel 104includes a stop member 190 at the first end 142 of the bore 110, such asa shoulder portion, that engages a portion of the distal end 122 of theobturator 106 to limit the distance the obturator 106 can travel towardthe end 142 of the barrel 104.

One embodiment of the obturator 106 includes one or more bore engagingmembers 196, embodiments of which are shown in FIG. 9. The one or morebore engaging members 196 are configured to engage the interior wall 117of the bore 110 and provide frictional resistance between the obturator106 and the barrel 104. The frictional resistance between the boreengaging members 196 and the interior wall 117 of the barrel 104operates to prevent undesired movement of the obturator 106 relative tothe barrel 104 during normal handling of the device 100C. When theneedled 116 secured by the clamp 108C is retracted within the barrel104, as illustrated in FIG. 8, the frictional resistance prevents theobturator 106 from sliding relative to the barrel 104 and extending theneedle 116 outside of the barrel 104.

In one embodiment, the bore engaging member or members 196 include asurface 198 that is radially displaced from the axis 112 a greaterdistance than other portions of the distal end 122 of the obturator 106.In one embodiment, a gap 199 is formed between the bore engaging member196 and the interior portion of the distal end 122 of the obturator 106.The gap 199 allows the bore engaging member 196 to deflect toward thecentral axis 112 responsive to contact between the surfaces 198 and thesurface 117 of the bore 110. In one embodiment, the bore engagingmembers 196 flex toward the axis 112 when installed within the bore 110of the barrel 104. The pressure applied to the interior wall 117 of thebore 110 by the surface 198 of the one or more bore engaging members 196generates the desired frictional resistance between the obturator 106and the barrel 104. In one embodiment, the one or more bore engagingmembers 196 comprises a ring-shaped member that is generally coaxial tothe axis 112. Alternatively, the bore engaging members 196 may comprisea plurality of components that are angularly displaced about the axis112.

Another embodiment of the invention is directed to a needle guard thatis configured to secure the needle 116 within the bore 110 of aprosthesis implantation device, such as the devices 100A-C describedabove. While the embodiments of the needle guard will be illustrated asbeing applied to the device 100A, it is understood that embodiments ofthe needle guard 200 may also be used with the devices 100B and 100C, orother similar device, in the same or similar manner.

FIG. 10 is a cross-sectional view of a needle guard 200 in accordancewith embodiments of the invention. It is understood that the end 114 ofthe needle 116, installed within the barrel 104, may be coupled tosutures 120 that are connected to a penile prosthesis 101, as shown inFIG. 1. These elements are not shown in order to simplify theillustration.

In one embodiment, the needle guard 200 is formed of plastic. Theattachment of the needle guard 200 to the device 100 operates to coverthe open end 142 of the barrel 104 to prevent the piercing end 118 ofthe needle 116 from sticking out. In one embodiment, the needle guard200 cradles the obturator 106 to prevent it from advancing the needle116 through the opening in the end 142 of the barrel 104.

One embodiment of the needle guard 200 comprises a first member 202, asecond member 204 and a third member 206. The first member 202 isconfigured to cover the opening 208 of the bore 110 at the first end142. In one embodiment, the first member comprises a surface 209, suchas a convex surface, that partially extends within the bore 110 of thebarrel 104. The second member 204 engages a first end 210 of theobturator 106 and the third member 206 couples the first and secondmembers of the needle guard 200 together.

In one embodiment, the obturator 106 includes a cross member 212 at thefirst end 210 that extends transversely from the longitudinal axis 112,and the second member 204 of the needle guard 200 engages the crossmember 212, as shown in FIG. 10. In one embodiment, the first and secondmembers 202 and 204 include portions that are inline with thelongitudinal axis 112 of the obturator 106. In one embodiment, theneedle guard 200 is partially secured to the device 100 through theapplication of a compressive force between the first and second members202 and 204 that is applied to the obturator 106 and the barrel 104.

One embodiment of the needle guard 200 includes a fourth member 214 thatis positioned between the cross member 212 and the barrel 104, as shownin FIG. 10. The fourth member is configured to limit movement of theobturator 106 toward the barrel 104 along the longitudinal axis 112. Asa result, one embodiment of the needle guard 200 operates to preventrelative movement between the obturator 106 and the barrel 104. Oneembodiment of the fourth member 214 comprises a portion 216 that engagesthe cross member 212 of the obturator and a portion 218 that engages thebarrel 104. While illustrated as being integral with or coupled to thirdmember 206, it is understood that the fourth member 214 can be formed asa separate component (i.e., non-integral to the needle guard 200) thatfits between the barrel 104 and the cross member 212.

In accordance with one embodiment, the fourth member 214 is securedbetween the cross member 212 and the barrel 104 due to an interferencefit there-between. In accordance with another embodiment, the fourthmember 214 is configured to snap-fit to the shaft 220 of the obturator106, as illustrated in the top plan view of the needle guard 200 shownin FIG. 11 with the obturator 106 and the barrel 104 illustrated inphantom lines. In one embodiment, the fourth member 214 includes atleast two opposing clip members such as clip member pair 222A and 222Bextending from portion 216, or clip member pair 224A and 224B extendingfrom portion 218. The gap 226 separating clip member pair 222A and 222Bor gap 228 separating clip member pair 224A and 224B is set such thatthe shaft 220 of the obturator 106 can be secured between the clipmember pairs 222A and 222B and/or 224A and 224B by an interference-fit.

FIG. 12 is a side view of the needle guard 200 in accordance withanother embodiment of the invention. This embodiment of the needle guard200 takes advantage of the stop member 140 (devices 100A and 100C) ofthe barrel 104 which prevents the obturator 106 from being pulled out ofthe second end 144 of the barrel 104. The device 100 is secured to theneedle guard 200 using the first member 202, the third member 206 andthe fourth member 214. In one embodiment, the portion 216 includes theclip members 222A and 222B (not shown) to provide the desired snap-fitor interference fit to the shaft 220 of the obturator 106.

One embodiment of the invention relates to a kit 230, embodiments ofwhich are illustrated in the schematic diagram of FIG. 13. Oneembodiment of the kit 230 includes one or more penile implantationdevices 100 formed in accordance with one or more of the embodimentsdescribed above. In one embodiment, the device 100 holds a needle 116 inthe needle clamp 108 formed in accordance with one or more of theembodiments described above. In one embodiment, the needle 116 isthreaded with a suture 120 and coupled to a tip end 102 of the penileprosthesis 101. The obturator 106 is placed in the retracted position,in which the needle 116 is fully received within the barrel 104. In oneembodiment, a needle guard 200, formed in accordance with one or moreembodiments described above, is installed on the device 100. In oneembodiment, the kit contains instructions 232 for using the device 100to implant the penile prosthesis. In one embodiment, system components234, such as pumps, fluid reservoirs and other components used in penileprosthetic systems are also included in the kit 230.

In one embodiment, a device holder 240 is used to attach one or more ofthe devices 100, penile prosthesis 101, and/or sutures 120 together, asillustrated in FIG. 13. In one embodiment, the device holder 240includes at least one device receiving portion 242, such as a slot or abore, configured to receive, or attach to, a device 100. The device 100is preferably sufficiently held by the portion 242 to allow for normalhandling of the device holder 240 while allowing the device 100 to beremoved from the portion 242 by hand. In one embodiment, the deviceholder 240 includes at least one prosthesis receiving portion 244configured to receive a penile prosthesis 101, such as a slot or a bore.The penile prosthesis 101 is preferably sufficiently held by the portion244 to allow for normal handling of the device holder 240 while allowingthe penile prosthesis 101 to be removed from the portion 242 by hand.

In one embodiment, the device holder is formed using a siliconeelastomer. Some advantages of such a material include its elasticity andability to accommodate the device and prosthesis, its biocompatibility,and its ability to be easily sterilized by common methods.

In one embodiment, the device holder 240 includes at least one suturereceiving portion 246 configured to receive the suture 120, such as aslot or a bore. The suture 120 is preferably sufficiently held by theportion 246 to allow for normal handling of the device holder 240 whileallowing the suture 120 to be removed from the portion 242 by hand. Inone embodiment, the portion 246 is in the form of a bore and the suture120 is wrapped up and inserted into the bore. When the device 100 andprosthesis 101 are removed from the portions 242 and 244, the suture 120can be pulled from the portion 246 without tangling the suture 120.Additionally, portion 246 is used to hold the suture 120 to prevent itfrom becoming tangled with the other components of the kit 230 duringshipment and handling.

In one embodiment, the kit 230 includes packaging 250 that contains oneor more of the components of the kit 230 described above. The componentsof the kit 230 are preferably sterilized in the packaging 250. Thepackaging 250 is then sealed.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A penile prosthesis implantation devicecomprising: a barrel having a bore; and an obturator received within thebore and configured to slide along a longitudinal axis of the borerelative to the barrel, the obturator comprising: a needle clampincluding one or more pinching members extending from a distal end ofthe obturator along the longitudinal axis, wherein the one or morepinching members include pinching surfaces that are configured to hold athread attachment end of a needle; and one or more bore engaging membersat the distal end of the obturator, the one or more bore engaging memberhaving a surface that engages an interior wall of the bore; and a gapextending between a central portion of the obturator and the one or morebore engaging members; wherein the one or more bore engaging membersdeflect toward the central portion and the longitudinal axis in responseto contact with the interior wall of the bore independently from the oneor more pinching members and the pinching surfaces.
 2. The device ofclaim 1, wherein the needle clamp comprises a receptacle between thepinching surfaces that is configured to receive a thread attachment endof a needle and hold the end of the needle through an interference fitwith the pinching surfaces.
 3. The device of claim 1, wherein the needleclamp extends from the central portion along the longitudinal axis. 4.The device of claim 1, wherein the surface of each of the one or morebore engaging members is radially displaced from the longitudinal axis agreater distance than the needle clamp.
 5. The device of claim 1,wherein the one or more bore engaging members comprise a ring-shapedmember that is coaxial to the longitudinal axis.
 6. The device of claim1, further comprising a needle guard comprising: a first member coveringan opening to the bore at a distal end of the barrel; a second memberengaging a proximal end of the obturator; and a third member coupled tothe first and second members of the needle guard; wherein the needleguard maintains the obturator in a retracted position within the bore.7. The device of claim 1, wherein the one or more pinching members aredisplaced along the longitudinal axis from the one or more bore engagingmembers and the central portion of the obturator.
 8. The device of claim1, wherein the gap extends in a plane that is perpendicular to thelongitudinal axis, and the longitudinal axis extends through a portionof the central portion that is within the plane.
 9. The device of claim8, wherein the one or more bore engaging members extend from the distalend of the obturator at a location that is displaced along thelongitudinal axis toward a proximal end of the obturator from the one ormore pinching members.